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A Phase IB Study of NGR-hTNF in Combination With Doxorubicin in Patients Affected by Advanced or Metastatic Solid Tumors

Phase 1
18 Years
Not Enrolling

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Trial Information

A Phase IB Study of NGR-hTNF in Combination With Doxorubicin in Patients Affected by Advanced or Metastatic Solid Tumors

This is a phase IB, open-label, non-randomized, dose-escalation study that will be conducted
in sequential cohorts of patients. Three patients per each cohort are planned.

Patients, with advanced or metastatic solid tumor previously treated with a non cumulative
dose of doxorubicin (<300 mg/sqm in order to allow an adequate number of cycles) or
chemotherapy naïve will be enrolled.

Inclusion Criteria:

- Patients ≥18 years old with proven advanced or metastatic solid tumor not amenable to
any clinical improvement by current standard treatments and previously treated with a
non cumulative dose of anthracyclines (<300 mg/sqm) or chemotherapy naïve.

- Life expectancy more than 3 months.

- ECOG performance status 0 - 2.

- Normal cardiac function (left ventricular ejection fraction [LVEF] ≥55%) and absence
of uncontrolled hypertension.

- Absence of any conditions involving hypervolemia and its consequences.

- Adequate baseline bone marrow, hepatic and renal function, defined as follows:

Neutrophils > 1.5 x 10^9/L and platelets >100 x 10^9/L Bilirubin < 1.5 x ULN AST and/or
ALT < 2 x ULN Serum creatinine < 1.5 x ULN

- Patients may have had prior therapy providing the following conditions are met:

- Chemo, radio, hormonal, immuno or anti-vascular therapy: wash-out period of 28

- Surgery: wash-out period of 14 days.

- Patients must give written informed consent to participate in the study.

Exclusion Criteria:

- Concurrent anticancer therapy

- Patients must not receive any other investigational agents while on study

- Patients with a LVEF <55%

- New York Heart Association class III or IV cardiac disease

- Acute angina

- Patients with myocardial infarction within the last six (6) months

- Patient with significant peripheral vascular disease

- Thrombosis of main portal vein

- Previous signs of severe toxicity doxorubicin related

- Previous signs of cardiotoxicity doxorubicin related

- Patients previously treated with a cumulative dosage of anthracyclines ≥300 mg/m^2

- Clinical signs of CNS involvement

- Patients with active or uncontrolled systemic disease/infections or with serious
illness or medical conditions, which is incompatible with the protocol

- Known hypersensitivity/allergic reaction to human albumin preparations or to any of
the excipients

- Any psychological, familial, sociological or geographical condition potentially
hampering compliance with the study protocol

- Pregnancy or lactation. Patients - both males and females - with reproductive
potential (i.e. menopausal for less than 1-year and not surgically sterilized) must
practice effective contraceptive measures throughout the study. Women of
child-bearing potential must provide a negative pregnancy test (serum or urine)
within 14 days prior to registration

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To verify the safety of escalating doses of NGR-hTNF in combination with a fixed dose of doxorubicin

Outcome Time Frame:

during and following treatment

Safety Issue:


Principal Investigator

Federico Caligaris Cappio, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fondazione San Raffaele del Monte Tabor


Italy: National Institute of Health

Study ID:




Start Date:

January 2006

Completion Date:

April 2008

Related Keywords:

  • Cancer
  • NGR-hTNF
  • doxorubicin
  • solid tumors